| Trial name or title |
Persistent methicillin‐resistant Staphylococcus aureus eradication protocol (PMEP). |
| Methods |
RCT ‐ participants will be assigned in a 1:1 ratio to either treatment or control group.
Design: parallel.
Location: dual centre in the USA.
Duration: 28 days with additional 3‐month follow‐up. |
| Participants |
40 participants with persistent respiratory tract MRSA infection will be enrolled in this trial.
Inclusion criteria:
male or female ≥ 12 years of age; confirmed diagnosis of CF based on the following criteria: positive sweat chloride > 60 mEq/liter (by pilocarpine iontophoresis) and/or a genotype with 2 identifiable mutations consistent with CF or abnormal NPD, and 1 or more clinical features consistent with the CF phenotype; written informed consent (and assent when applicable) obtained from participant or participants's legal representative and ability for participant to comply with the requirements of the trial; 2 positive MRSA respiratory cultures in the last 2 years at least 6 months apart, plus a positive MRSA respiratory culture at screening visit and run‐in (day 14) visit; at least 50% of respiratory cultures from the time of the first MRSA culture (in the last 2 years) have been positive for MRSA; FEV1 > 30% of predicted normal for age, gender, and height at screening; females of childbearing potential must agree to practice 1 highly effective method of birth control, including abstinence. Note: highly effective methods of birth control are those, alone or in combination, that result in a failure rate less than 1% per year when used consistently and correctly. Female participants who utilize hormonal contraceptives as a birth control method must have used the same method for at least 3 months before trial dosing. If the participant is using a hormonal form of contraception, she will be required to also use barrier contraceptives as rifampin can affect the reliability of hormone therapy. Barrier contraceptives such as male condom or diaphragm are acceptable if used in combination with spermicides.
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| Interventions |
Treatment group: 28‐day course of vancomycin for inhalation (250 mg 2x daily) plus oral rifampicin and oral TMP‐SMX.
Control group: taste‐matched inhaled placebo (sterile water) plus oral rifampicin and oral TMP‐SMX.
In addition, both groups will receive oral rifampin, a second oral antibiotic (TMP‐SMX or doxycycline, protocol determined), mupirocin intranasal cream and chlorhexidine body washes |
| Outcomes |
Primary outcomes
to determine the efficacy of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF. to determine the safety of an aggressive treatment protocol in eradicating persistent MRSA infection in individuals with CF.
Secondary objectives
to determine the efficacy of an aggressive treatment protocol in improving FEV1, time to next exacerbation, and quality of life in individuals with CF and persistent MRSA infection. to determine if there is benefit to adding nebulized vancomycin to an aggressive oral antibiotic treatment protocol in eradicating persistent MRSA infection in individuals with CF.
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| Starting date |
Oct 2012. |
| Contact information |
Michael Boyle, Associate Professor of Medicine, Johns Hopkins University. |
| Notes |
Currently actively recruiting. Estimated completion date: March 2015. |
